Hypomethylating agents combined with low-dose chemotherapy for elderly patients with acute myeloid leukaemia unfit for intensive chemotherapy: a real-world clinical experience

Abstract

This study aimed to assess the efficacy and safety of hypomethylating agent (HMA)-based regimens in the treatment of older adult patients with acute myeloid leukaemia (AML), unfit for standard induction chemotherapy. Treatment outcomes and prognostic factors of 140 older adult patients with AML who were unfit for intensive chemotherapy and were treated with HMA-based therapies were retrospectively analysed. The median age of the group was 70 years, and poor-risk cytogenetics and secondary/treatment-related AML (s/t-AML) accounted for 45.6% and 34.3% of these patients, respectively. The overall response rate was 48.6%, and 40.1% for patients who achieved complete remission (CR) or CR with incomplete blood count recovery. The median overall survival (OS) was 10.4 months, and the 1-, 2-, and 5-year OS rates were 42.6%, 19.9%, and 4.9%, respectively. Early mortality accounted for 4.3% of all cases, and infection occurred in 87.1% of all patients during induction therapy. Patients who received HMA and low-dose chemotherapy presented with significantly superior response and long-term survival rates compared to those who received HMA alone. They also showed comparable outcomes to those treated with the azacitidine plus venetoclax protocol. Low-dose chemotherapy in combination with decitabine or azacitidine showed a similar response rate and prognosis. Age ≥ 75years and a white blood cell (WBC) count ≥ 10 × 109 cells/L were identified as independent adverse prognostic factors for OS, while poor-risk cytogenetics, percentage of bone marrow blasts, and s/tAML had no significant impact on OS when patients were treated with HMA-based regimens. In conclusion, HMA combined with low-dose chemotherapy was effective and safe in older adults with AML who were unfit for intensive chemotherapy, and no difference was observed between decitabine and azacitidine.

Keywords:

• Acute myeloid leukaemia
• older adult
• unfit
• hypomethylating agents
• chemotherapy
• clinical experience

Author contributions

Yi Chen integrated and wrote this manuscript; Jing Cao and Yaozhen Ye collected the materials; Luting Luo and Xiaoyun Zheng, and Xiaozhu Yang analyzed the data; Zhihong Zheng, Jing Zheng and Ting Yang were responsible for quality control; Jianda Hu was responsible for this study.

Conflict of interest statement

The authors have no conflicts of interest to declare.

Data availability statement

The data that support the findings of this study are included in this article. Further enquirers can be directed to the corresponding author.

Ethics statement

The research was conducted ethically in accordance with the World Medical Association Declaration of Helsinki, and all patients provided written informed consent for treatment. This study was approved by the institutional ethics committee of Fujian Medical University Union Hospital, and the reference number was 2022KY077.

Additional information

Funding

This study was supported by Startup Fund for scientific research, Fujian Medical University (Grant number: 2020QH1079), Construction project of Fujian medical center of hematology (Min201704), National Natural Science Foundation of China (81870135, U2005204, 82000142), National Key Clinical Specialty Discipline Construction Program (2021-76), Fujian Provincial Clinical Research Center for Hematological Malignancies (2020Y2006).